Hulskof schreef op 19 februari 2020 22:20:
Lekker hoor, ook bij Heron wordt de boel vertraagd, 3 maanden.
Een reden wordt niet gegeven.
SAN DIEGO, Feb. 19, 2020 /PRNewswire/ -- Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, today announced that the U.S. Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) for HTX-011 by up to three months. The new PDUFA goal date is June 26, 2020.
A Complete Response Letter (CRL) was received from the FDA regarding the NDA for HTX-011 on April 30, 2019 relating to chemistry, manufacturing and controls and non-clinical information. Heron is pleased to report that the contract manufacturing site used to manufacture HTX-011 has been reinspected by the FDA with no Form 483 observations issued and with a recommendation by the FDA inspector for approval of the site. Heron has not been informed of any other manufacturing concerns. There were no clinical efficacy or safety issues in the CRL.
"While the three-month extension of the review clock for the HTX-011 NDA resubmission is very disappointing, the FDA indicated that they will try to complete their work in less time," said Barry Quart, Pharm.D., President and Chief Executive Officer of Heron. "We are gratified with the positive outcome of the FDA reinspection of the HTX-011 contract manufacturing facility, which was an important factor in the CRL."
Positief in elk geval dat de site is goedgekeurd. Dan mogen we er al stiekem van uitgaan dat HTX-011 wordt goedgekeurd. Nog even geduld dus.